Emergo by UL Regulatory Recap: Global Trends November 2018
Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices
This is our second installment of global medical device regulatory updates and observations related to global trends. In the past few months (July through November 2018), we have observed data to support several global trends. We could wax philosophical on what constitutes a trend, though suffice it to say, our professional judgement has identified the following themes:
- Initiatives that enhance device tracking and traceability,
- The increasing activity of the Medical Device Single Audit Program or MDSAP (in spite of Health Canada’s newly announced flexibility), and
- Proposals to simplify the regulatory process for the lowest risk medical devices.
The IMDRF continues to foster harmonization among the medical device regulators, and in this context sets the framework for many of these initiatives.
Global Post-Market Surveillance (PMS): Device traceability and tracking
Globally there continues to be an interest in collection of total product lifecycle data, and in digital and regulatory initiatives that facilitate data collection on explicit devices supplied to the market.
- IMDRF: The IMDRF published three draft UDI documents (7/12/2018) N48, N53, and N54. The consultation of these documents closed in mid-October. This represents significant efforts made by the IMDRF as N54 is a tome of a draft UDI System Application Guide.
- EU: In this period, the Medical Device Coordination Group (MDCG) released five guidance documents on UDI.
- China NMPA: We had previously reported that the CFDA was to be renamed the CDA. Our tea leaves were inaccurate, and the moniker adopted by the regulators was actually National Medical Products Administration (NMPA). The NMPA has released a revised UDI document (link in Chinese) for consultation. Again, consultation has been closed though this further advances the countries’ interest in implementing a UDI system for medical devices. Generally related to PMS, the NMPA has announced an interest in data on total product life cycle and PMS.
- Brazil ANVISA: Related to the ANVISA National Implant Registry (RNI), RDC 232/2018 (links in Portuguese) was promulgated to require GS1 or HIBCC barcodes on labels of coronary stents and hip and knee prostheses, effective June 2020.
Our discussion from our last blog post, doesn’t waiver: Regulators are assiduously working to implement systems for device traceability (UDI). This trend will only continue to develop as other regulators adopt these initiatives.
Interest in the Medical Device Single Audit Program (MDSAP) strengthens (from both regulators and medical device manufacturers), enough to warrant a separate section in our blog this time. Our experience suggests there is a four-to-six- month delay in receiving an issued MDSAP certificate, though we continue to observe more clients interested in securing a MDSAP certificate. The US FDA publishes and maintains a list of the Auditing Organizations (AOs) authorized and recognized to conduct MDSAP Audits. ANVISA, as required by Brazilian legislation, continues to publish in its official DOU AOs that have been officially recognized.
The South Korean Ministry of Food and Drug Safety (MFDS) proposed revisions to its legislation QMS (KGMP) regulation (link in Korean) to align with ISO 13485:2016 and to further align the MFDS with MDSAP. Emergo has blogged on this topic extensively.
Health Canada was the first regulator to promulgate legislation to require MDSAP certification, and has demonstrated some flexibility. Details are posted to the Health Canada website. Emergo by UL consultants attended a Health Canada update at MEDEC (October 25, 2018), and surprisingly, the number of cancelled or withdrawn Medical Device Licenses (MDLs) and manufacturers who have pulled out of Canada are lower than expected. Health Canada is closely monitoring manufacturers who exit the Canadian market , and has indicated willingness to assist manufacturers through the transition. Note: manufacturers should provide evidence to demonstrate that they have tried to secure the MDSAP certification audit dates as well.
Excitement and interest in MDSAP is growing. More manufacturers appear to be interested in the concept, and more AOs are becoming officially recognized. The medical device enterprise, of course, will need to temper their optimism, as we all continue to be concerned about the paucity of medical regulatory and compliance resources.
Simplification of regulatory processes for lowest-risk medical devices
We have compiled several examples where lower risk medical devices now (or will now) have a simplified regulatory process, or for which the entire regulatory process will be eased.
Earlier this year, the Medical Devices of the Pharmacopoeia, 4th edition (2/22/2018) was published with a revised Appendix II, on Mexican medical device classification rules, which introduced three more classification rules (increasing from 20 to 23). Rule 23 is essentially a catch-all for low-risk medical devices. To this end, CANIFARMA (Cámara Nacional de la Industria Farmacéutica) has solicited Emergo to add products that should now be added to either the unregulated list or Class A Low Risk medical device list as a consequence of the revised legislation. The deadline is November 15, 2018, at which point we would expect COFEPRIS to release revised lists.
While Chinese medical device regulatory updates aren’t necessarily a simplification of the lowest-risk medical device registration process, they are favorable for the entire registration exercise.
The then-CFDA reported to Emergo by UL consultants attending a CIMDR Seminar in August 2018 some measures related to facilitating Class II and III registrations. A comprehensive medical device and IVD Clinical Trial Exemption Lists (Announcement No. 94 of 2018) has been published. This now totals 1,238 products. And, related to the Revisions to Order No. 43 , less PMS data needs to be submitted for a renewal because the expectation is that the NMPA will focus on PMS in general. (Links in Chinese.)
The TGA announced on August 20, 2018 that, in addition to conformity assessment issued by TGA and European Notified Bodies, they will also begin accepting approvals from the following comparable overseas regulators/assessment bodies for medical devices: the US FDA, Health Canada, MDSAP certificates, and Japan’s MHLW. Emergo by UL consultants note that the TGA’s eBS system now accepts these other forms of evidence.
These developments are all interesting as they are expected to make medical device and IVD regulatory systems more efficient, while again emphasizing the importance of PMS systems. The medical device enterprise welcomes measures that facilitate the operation of regulatory systems while preserving the safety and performance of medical devices!
Evangeline Loh, Ph.D., RAC is Global Regulatory Manager at Emergo by UL.